Quality Manager (Lab Ops / GMP)
SURESNES, 92
il y a 2 jours
As our first dedicated Quality Manager, you will bridge the gap between high-speed innovation and rigorous regulatory compliance. Your mission is to design and implement a Quality Management System (QMS) that supports our increased production needs and ensures our new lab setup meets the gold standard for global veterinary medicine.
Main Responsibilities
QMS Design
- Build from Scratch: Design, implement, and maintain a robust QMS compliant with applicable biotech and pharmaceutical guidelines.
- Audit Leadership: Manage the internal audit program across all operational areas to ensure constant readiness.
- Supply Chain Integrity: Oversee the qualification and auditing of all suppliers and subcontractors.
- Knowledge Culture: Design and deliver training programs on documentation standards and quality procedures for the whole team.
GMP & Regulatory Support
- Lab Setup: Lead all quality aspects of the incoming GMP lab setup, including site qualification, equipment validation, and cleanroom procedures.
- Global Submissions: Act as a key pillar in the preparation of regulatory dossiers from a quality and GMP compliance perspective.
- Release Authority: Ensure batch release procedures are defensible, rigorous, and in place for all products released to the field.
Monitoring & Continuous Improvement
- Incident Response: Lead post-incident quality reviews following field deviations or high-mortality cases to ensure we never stop learning.
- Early Integration: Participate in new product and process development, acting as a proactive voice to raise quality issues during the design phase rather than after.
What We’re Looking For
- Education: Degree in Pharmacy, Biology, Biotechnology, or a related life science discipline.
- Experience: Minimum 3-4 years in a quality role within a regulated biotech, pharma, or veterinary medicine environment.
- Technical Skills: Solid working knowledge of GMP guidelines; familiarity with veterinary medicinal product regulations is a massive plus; proficiency in designing and managing QMS software and documentation.
- Soft Skills: Comfortable with ambiguity, proactive in high-pressure situations, and able to translate complex regulations into clear team actions.
- Languages: Fluent in English.
What We Offer
- International Culture: Work with a global, diverse team driven by a shared vision of impactful biotechnology.
- Impactful Work: Lead processes that contribute directly to innovative biotechnologies.
- Growth & Learning: Gain valuable technical experience in a fast-paced environment.
- Well-being Perks: Free breakfast, sports activities, and a healthy work-life balance culture.
If you’re excited by science with real-world impact and want to help rewrite the future of animal health—we’d love to chat.
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Entreprise
Entrepreneur First
Plateforme de publication
WHATJOBS
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